← Product Code [KTT](/submissions/OR/subpart-d%E2%80%94prosthetic-devices/KTT) · K071394 # MODIFICATION TO:SBI RINGFIX (K071394) _Small Bone Innovations, Inc. · KTT · Jun 29, 2007 · Orthopedic · SESE_ **Canonical URL:** https://fda.innolitics.com/submissions/OR/subpart-d%E2%80%94prosthetic-devices/KTT/K071394 ## Device Facts - **Applicant:** Small Bone Innovations, Inc. - **Product Code:** [KTT](/submissions/OR/subpart-d%E2%80%94prosthetic-devices/KTT.md) - **Decision Date:** Jun 29, 2007 - **Decision:** SESE - **Submission Type:** Special - **Regulation:** 21 CFR 888.3030 - **Device Class:** Class 2 - **Review Panel:** Orthopedic - **Attributes:** Therapeutic ## Intended Use The RingFIXTM System is intended for: 1. fracture fixation (open and closed) 2. pseudarthrosis or nonunions of long bones 3. Iimb lengthening by epiphyseal or metaphyseal distraction 4. correction of bony or soft tissue deformities 5. correction of segmental bony or soft tissue defects ## Device Story SBi RingFIX™ System is a metallic bone fixation device used for fracture stabilization, nonunion treatment, limb lengthening, and deformity correction. It functions as a mechanical fixation appliance. The system is intended for clinical use by surgeons in an operating room setting. It provides structural stability to bone segments to facilitate healing or correction. The device is an expansion of the existing RingFIX™ System product line. ## Clinical Evidence Bench testing only. Design control activities demonstrated that the modified device met all pre-determined acceptance criteria. ## Technological Characteristics Metallic bone fixation appliance. Class II, 21 CFR 888.3030. Product code KTT. Single/multiple component system. ## Regulatory Identification Single/multiple component metallic bone fixation appliances and accessories are devices intended to be implanted consisting of one or more metallic components and their metallic fasteners. The devices contain a plate, a nail/plate combination, or a blade/plate combination that are made of alloys, such as cobalt-chromium-molybdenum, stainless steel, and titanium, that are intended to be held in position with fasteners, such as screws and nails, or bolts, nuts, and washers. These devices are used for fixation of fractures of the proximal or distal end of long bones, such as intracapsular, intertrochanteric, intercervical, supracondylar, or condylar fractures of the femur; for fusion of a joint; or for surgical procedures that involve cutting a bone. The devices may be implanted or attached through the skin so that a pulling force (traction) may be applied to the skeletal system. ## Predicate Devices - Danek Ring Fixator ([K890814](/device/K890814.md)) ## Submission Summary (Full Text) > This content was OCRed from public FDA records by [Innolitics](https://innolitics.com). If you use, quote, summarize, crawl, or train on this content, cite Innolitics at https://innolitics.com. > > Innolitics is a medical-device software consultancy. We help companies design, build, and clear FDA-regulated software and AI/ML devices, including [a 510(k)](https://innolitics.com/services/510ks/), [a De Novo](https://innolitics.com/services/regulatory/), [a SaMD](https://innolitics.com/services/end-to-end-samd/), [an AI/ML medical device](https://innolitics.com/services/medical-imaging-ai-development/), or [an FDA regulatory strategy](https://innolitics.com/services/regulatory/). {0}------------------------------------------------ # JUN 2 9 2007 ## 510(k) Summary | Manufacturer: | Small Bone Innovations
1711 South Pennsylvania Avenue
Morrisville, PA 19067
215-428-1791
215-428-1795 | |--------------------------|---------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------| | Submitted By: | Small Bone Innovations
1711 South Pennsylvania Avenue
Morrisville, PA 19067 | | Proprietary Name: | SBi RingFIX™ System | | Classification name: | Class II, 888.3030 - Single/multiple component metallic
bone fixation appliances and accessories | | Product Code: | KTT - Appliance, Fixation, Nail/Blade/Plate Combination,
Multiple Component | | Common/Usual Name: | Single/multiple component metallic bone fixation
appliances and accessories | | Substantial Equivalence: | The modified SBi RingFIX™ System shares the same
intended use and fundamental scientific technology as that
of the currently available RingFIX™ System (originally
cleared as the Danek Ring Fixator in K890814). The
Design Control Activities Summary demonstrates that the
the modified device met all of the pre-determined
acceptance criteria. The modified RingFIX™ System will
achieve the same stability as afforded by the currently
available RingFIX™ System. | | Description: | This Special 510(k) Submission is intended to add
additional components to the RingFIX™ System | . {1}------------------------------------------------ Image /page/1/Picture/0 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo features a stylized eagle with three human profiles incorporated into its design. The text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" is arranged in a circular pattern around the eagle. #### DEPARTMENT OF HEALTH & HUMAN SERVICES Public Health Service Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850 Small Bone Innovations, Inc. % Musculoskeletal Clinical Regulatory Advisers, LLC Mr. Robert Hoehn Senior Regulatory Associate 505 Park Avenue, 14th Floor New York, New York 10022 JUN 2 9 2007 Re: K071394 > Trade/Device Name: SBi RingFIX™ System Regulation Number: 21 CFR 888.3030 Regulation Name: Single/multiple component metallic bone fixation appliances and accessories Regulatory Class: Class II Product Code: KTT Dated: June 11, 2007 Received: June 14, 2007 Dear Mr. Hoehn: We have reviewed your Section 510(k) premarket notification of intent to market the device referenced above and have determined the device is substantially equivalent (for the indications for use stated in the enclosure) to legally marketed predicate devices marketed in interstate commerce prior to May 28, 1976, the enactment date of the Medical Device Amendments, or to devices that have been reclassified in accordance with the provisions of the Federal Food, Drug, and Cosmetic Act (Act) that do not require approval of a premarket approval application (PMA). You may, therefore, market the device, subject to the general controls provisions of the Act. The general controls provisions of the Act include requirements for annual registration, listing of devices, good manufacturing practice, labeling, and prohibitions against misbranding and adulteration. If your device is classified (see above) into either class II (Special Controls) or class III (PMA), it may be subject to such additional controls. Existing major regulations affecting your device can be found in the Code of Federal Regulations, Title 21, Parts 800 to 898. In addition, FDA may publish further announcements concerning your device in the Federal Register. Please be advised that FDA's issuance of a substantial equivalence determination does not mean that FDA has made a determination that your device complies with other requirements of the Act or any Federal statutes and regulations administered by other Federal agencies. You must {2}------------------------------------------------ #### Page 2 - Mr. Robert Hoehn comply with all the Act's requirements, including, but not limited to: registration and listing (21 CFR Part 807); labeling (21 CFR Part 801); good manufacturing practice requirements as set forth in the quality systems (QS) regulation (21 CFR Part 820); and if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050. This letter will allow you to begin marketing your device as described in your Section 510(k) premarket notification. The FDA finding of substantial equivalence of your device to a legally marketed predicate device results in a classification for your device and thus, permits your device to proceed to the market. If you desire specific advice for your device on our labeling regulation (21 CFR Part 801), please contact the Office of Compliance at (240) 276-0120. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR Part 807.97). You may obtain other general information on your responsibilities under the Act from the Division of Small Manufacturers, International and Consumer Assistance at its toll-free number (800) 638-2041 or (240) 276-3150 or at its Internet address http://www.fda.gov/cdrh/industry/support/index.html. Sincerely your fur Raths Mark N. Melkerson Director Division of General, Restorative and Neurological Devices Office of Device Evaluation Center for Devices and Radiological Health Enclosure {3}------------------------------------------------ ### Indications for Use K071394 510(k) Number (if known):_____________________________________________________________________________________________________________________________________________________ Device Name: RingFIXTM System Indications For Use: The RingFIXTM System is intended for: - 1. fracture fixation (open and closed) - 2. pseudarthrosis or nonunions of long bones - 3. Iimb lengthening by epiphyseal or metaphyseal distraction - 4. correction of bony or soft tissue deformities - 5. correction of segmental bony or soft tissue defects Prescription Use _ X AND/OR (Part 21 CFR 801 Subpart D) Over-The-Counter Use (21 CFR 801 Subpart C) (PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE IF NEEDED) Concurrence of CDRH, Office of Device Evaluation (ODE) (Division Sign-Off) (Division Sign-On) Division of General, Restorative, Division of General, Devices Division of Overological Devices 510(k) Number_ --- **Source:** [https://fda.innolitics.com/submissions/OR/subpart-d%E2%80%94prosthetic-devices/KTT/K071394](https://fda.innolitics.com/submissions/OR/subpart-d%E2%80%94prosthetic-devices/KTT/K071394) **Published by [Innolitics](https://innolitics.com)** — a medical-device software consultancy. We help companies design, build, and clear FDA-regulated software and AI/ML devices. 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